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Biomedical subjects

J P Gisbert

Publications and source records attributed to J P Gisbert.

At least 19 recordsLinked to original sources

Systematic review: Infliximab therapy in ulcerative colitis.

AIM: To perform a systematic review and meta-analysis on the efficacy and tolerance of infliximab in ulcerative colitis. METHODS SELECTION OF STUDIES: evaluating efficacy of infliximab in ulcerative colitis. For the meta-analysis, randomized clinical trials comparing infliximab vs. placebo/steroids. SEARCH STRATEGY: electronic and manual. Study quality: independently assessed by two reviewers. DATA SYNTHESIS: meta-analysis combining the odds ratios (OR). RESULTS: Thirty-four studies (896 patients) evaluated infliximab therapy in UC, with heterogeneous results. Mean short-term (2.3 weeks) response and remission with infliximab was 68% (95% CI 65-71%) and 40% (36-44%). Mean long-term (8.9 months) response and remission was 53% (49-56%) and 39% (35-42%). Five randomized double-blind studies compared infliximab with placebo, the meta-analysis showing an advantage (P < 0.001) of infliximab in all endpoints (short-/long-term response/remission): ORs from 2.7 to 4.6, and number-needed-to-treat (NNT) from 3 to 5. Similar infliximab response was calculated independently of the indication (steroid-refractory/non-steroid-refractory) or the dose (5/10 mg/kg). Adverse effects were reported in 83% and 75% of the infliximab and placebo-treated patients (OR = 1.52; 95% CI 1.03-2.24; number-needed-to-harm (NNH) was 14). CONCLUSION: Infliximab is more effective than placebo, with an NNT from 3 to 5, for the treatment of moderate-to-severe UC, achieving clinical remission in 40% of the patients at approximately 9 months of follow-up. Further studies are necessary to confirm the long-term efficacy of infliximab in ulcerative colitis.

Adolescent↗

Third-line rescue therapy with levofloxacin is more effective than rifabutin rescue regimen after two Helicobacter pylori treatment failures.

BACKGROUND: In patients with a first eradication failure, a second (rescue) therapy still fails in > 20% of cases. AIM: To compare rifabutin and levofloxacin rescue regimens in patients with two consecutive Helicobacter pylori eradication failures. METHODS: Patients, in whom first treatment with omeprazole-clarithromycin-amoxicillin and a second trial with omeprazole-bismuth-tetracycline-metronidazole (or ranitidine bismuth citrate with these antibiotics) had failed, received 10 days of treatment with either rifabutin (150 mg b.d.) or levofloxacin (500 mg b.d.), plus amoxicillin (1 g b.d.) and omeprazole (20 mg b.d.). Cure rates were evaluated by the (13)C-urea breath test. RESULTS: Twenty patients received rifabutin, and 20 levofloxacin. All the patients returned for follow-up. Compliance in the rifabutin group was 100%. Four patients in the levofloxacin group did not take the medication correctly (in two cases due to adverse effects: myalgia and rash). Side effects in the rifabutin and levofloxacin groups were reported in 60% and 50% of the cases, respectively. Five patients (25%) treated with rifabutin presented with leucopenia, and six (30%) treated with levofloxacin presented with myalgias. Per-protocol cure rates were 45% (95% confidence interval, 26-66%) in the rifabutin group, and 81% (57-93%) in the levofloxacin group (P < 0.05). Intention-to-treat cure rates were, 45% (26-66%) and 85% (64-95%), respectively (P < 0.01). CONCLUSIONS: After two previous H. pylori eradication failures, a 10-day triple levofloxacin-based rescue regimen is more effective than the same regimen with rifabutin.

Aged↗

A pilot study of atorvastatin treatment in dyslipemid, non-alcoholic fatty liver patients.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) encompasses a wide spectrum of liver injury. Currently, there are no proven effective therapies available. Atorvastatin is a new 3-hydroxy-3-metylglutaryl coenzyme A reductase inhibitor that reduces lipid serum levels. AIM: To evaluate the effectiveness and safety of atorvastatin in dyslipemid, non-alcoholic fatty liver patients. PATIENTS AND METHODS: We prospectively enrolled 25 patients with NAFLD; 22 of them completed the study. Body mass index, serum lipids, liver function tests and liver density assessed by echography were measured at baseline and after 1, 3, 6, 9 and 12 months of treatment. Normalization of transaminases and/or improvement in liver density were treatment end points. Patients received atorvastatin (10-80 mg/daily) according to basal serum choleresterol levels; additionally, they were given standard weight-loss counselling and encouraged to follow a low fat diet. RESULTS: All 22 patients (14 men, mean age 47 +/- 10 years) had high cholesterol levels at baseline and 11 (44%) also presented high trygliceride levels. After 6 months of treatment, eight patients (36.3%) presented normal transaminase levels. The remaining patients continued treatment for 12 months when 20% of patients presented with normal transaminase levels, while the other patients showed a 10% reduction in basal levels. Mean cholesterol levels were 268.5 +/- 44.2 and 186.8 +/- 14.4 mg/dL before and after treatment, respectively (P < 0.05). The mean body mass index was 27.4 +/- 3.1 at baseline and 26.3 +/- 2.8 kg/cm2 at the end of treatment (P > 0.05). No side effects were reported. CONCLUSIONS: Serum aminotransferase and lipid levels were reduced significantly in all patients with atorvastatin treatment. Therapy with atorvastatin in NAFLD patients with hyperlipidemia was found to be both effective and safe.

Adult↗

Recurrence of Helicobacter pylori infection after several eradication therapies: long-term follow-up of 1000 patients.

AIM: To study the incidence of Helicobacter pylori recurrence, its chronological aspects, and the variables that might influence it. METHODS: A total of 1000 patients in whom H. pylori had been eradicated were prospectively studied. Therapies were classified as low and high efficacy regimens. Four to eight weeks after completion of therapy, 13C-urea-breath-test was performed, and it was repeated yearly up to 5 years. In some patients, endoscopy with biopsies was also performed to confirm H. pylori eradication. RESULTS: A total of 1000 patients were included, giving 2744 patient-years of follow-up. Seventy-one H. pylori recurrences were observed (2.6% per patient-year). Probability of being H. pylori-negative at 1 year was 94.7%, and at 5 years 90.7%. In the multivariate analysis, low age (OR: 1.84; 95% CI: 1.04-3.26) and low efficacy therapies (OR: 2.5; 1.23-5.04) correlated with 1-year H. pylori recurrence. Differences were observed when Kaplan-Meier curves were compared depending on age and therapy regimen. CONCLUSION: Risk of posteradication H. pylori recurrence is higher during the first year, which suggests that most recurrences during this period are recrudescence and not true reinfections. H. pylori recurrence is more frequent in younger patients and in those treated with low efficacy therapies, but is exceptional if high efficacy therapies are used, in which case post-therapy eradication can be safely confirmed at 4 weeks with 13C-urea-breath-test.

Amoxicillin↗

Long-term follow-up of 13C-urea breath test results after Helicobacter pylori eradication: frequency and significance of borderline delta13CO2 values.

BACKGROUND: The precise choice of cut-off point for the 13C-urea breath test to define whether it is positive or negative represents a controversial issue. AIM: To quantify the 13C-urea breath test result for several years following Helicobacter pylori eradication, and to evaluate the frequency and the significance of borderline delta13CO2 values. METHODS: Two-hundred H. pylori eradicated patients confirmed by 13C-urea breath test (100 mg of urea, citric acid), and having had repeated this test yearly up to 5 years, were studied. Delta13CO2 values between 2 and 5/1000 were considered as borderline results. RESULTS: Eight H. pylori recurrences were observed during 406 patient-years of follow-up (1.97% yearly). In two of eight reinfected patients, the reinfection was preceded by a negative delta13CO2 value >2/1000. Borderline delta13CO2 values were detected in 4% of the 606 urea breath tests performed, and in 25% when only patients in whom H. pylori recurrence was detected in subsequent urea breath tests were included (P < 0.05). The negative-predictive value of a post-treatment delta13CO2 >2/1000 for the diagnosis of H. pylori recurrence was 99%. CONCLUSIONS: Positive and negative urea breath test results tend to cluster outside the range between 2/1000 and 5/1000. Nevertheless, a borderline urea breath test delta value (e.g. very close to the selected cut-off point) should be interpreted cautiously, and the result should probably be confirmed either by repeating the urea breath test or by other diagnostic methods. On the contrary, a delta13CO2 value <2/1000 very confidently confirms H. pylori eradication.

Breath Tests↗

Systematic review and meta-analysis: levofloxacin-based rescue regimens after Helicobacter pylori treatment failure.

BACKGROUND: A quadruple therapy has been generally recommended as rescue regimen for Helicobacter pylori eradication failures. AIMS: To systematically review the efficacy and tolerance of levofloxacin-based rescue regimens, and to conduct a meta-analysis of studies comparing these regimens with quadruple therapy for H. pylori eradication failures. METHODS: Selection of studies -- levofloxacin-based rescue regimens. For the meta-analysis, randomized-controlled trials comparing levofloxacin-based and quadruple regimens. Search strategy -- electronic and manual. Assessment of study quality -- independently by two reviewers. Data synthesis --'intention-to-treat' eradication rate. RESULTS: Mean eradication rate with levofloxacin-based regimens was 80%. Ten-day regimens were more effective than 7-day combinations (81% vs. 73%; P < 0.01). The meta-analysis showed better results with levofloxacin than with the quadruple combination (81% vs. 70%; OR = 1.80; 95% CI = 0.94-3.46). This difference reached statistical significance and heterogeneity markedly decreased when a single outlier study was excluded or when only high-quality studies were considered. Meta-analysis showed less adverse effects with levofloxacin than with quadruple regimen, both overall (19% vs. 44%; OR = 0.27; 95% CI = 0.16-0.46) and regarding severe adverse effects (0.8% vs. 8.4%; OR = 0.20; 95% CI =0.06-0.67). CONCLUSIONS: After H. pylori eradication failure, levofloxacin-based rescue regimen is more effective and better tolerated than the generally recommended quadruple therapy. A 10-day combination of levofloxacin-amoxicillin-proton pump inhibitor constitutes an encouraging second-line alternative.

Antacids↗

Spanish scientific output on Helicobacter pylori. A study through Medline.

OBJECTIVES: to analyze scientific output from Spanish hospitals in relation to Helicobacter pylori infection. METHODS: papers collected from the Medline database between January 1988 and December 2003 were selected. Our search strategy was: "Helicobacter pylori" [MeSH] AND ((Spain [AD] OR Espana [AD] OR Spanien [AD] OR Espagne [AD] OR Espanha [AD]) OR (Spanish [LA]) OR Spain). The following was analyzed: geographic area, Spanish or foreign publication, topic, and year of publication. Output and impact bibliometric markers were evaluated. RESULTS: in all, 691 papers were identified, of which 241 were excluded. Number of papers went from 2 in 1988 to 47 in 2002 and 13 in 2003. There were more reports in Spanish versus foreign journals (58 vs. 42%). In the first 5 years the areas with greater output were associated with diagnosis and microbiology (33 and 20%), whereas therapy was the predominating subject during the last 5 years (27%). Original papers were most common among publications (69%). Hospitals with highest output included La Princesa (24%) and Ramón y Cajal (17.6%) in Madrid, and Parc Taulí in Barcelona (6.4%). Mean impact factor progressively increased from 1.826 in 1988 to 2.142 in 2002 and 2.493 in 2003. CONCLUSIONS: the production and impact of documents published by Spanish scientists regarding H. pylori infection considerably increased during the past two decades.

Bibliometrics↗

The colorectal carcinoma prognosis factors. Significance of diagnosis delay.

INTRODUCTION: detection of early-stage colorectal carcinoma (CRC)--( Dukes A or B)--provides better survival rates in these patients. Thus, the effectiveness of screening programs in asymptomatic patients or of early diagnosis in symptomatic individuals has been postulated. The aim of this study was to establish whether a delay in diagnosis or other factors are related to CRC stage. PATIENTS AND METHODS: a retrospective study was performed on 96 patients with CRC. Age at diagnosis, gender distribution, intestinal disorders, diagnosis delay, primary sign and -regarding CRC- localization, stage (Dukes) and grade of differentiation (well differentiated; non-well differentiated; poorly differentiated) were recorded. RESULTS: diagnosis delay was 185 +/- 190 days. Patients delay in obtaining a diagnosis was 119 +/- 158 days. In 40% of patients CRC was diagnosed at an early stage (Dukes A or B), and in 13% CRC was poorly differentiated. The only factor with an independent effect on Dukes stage was tumor differentiation (p: 0.0012). Distal location was associated with less advanced tumors without statistical significance (p: 0.156). CONCLUSION: based on the presented data, a greater effort regarding screening programs for healthy people seems warranted, as improved survival has been demonstrated when diagnosis delay is reduced, particularly in patients with the highest mean delay.

Age Factors↗

Gastric angiogenesis and Helicobacter pylori infection.

The formation of new blood vessels seen in conditions commonly associated with Helicobacter pylori (H. pylori) infection, including gastritis, peptic ulcer, and gastric carcinoma, prompts consideration of a potential relationship between mucosal colonization by this organism and the angiogenic process. H. pylori directly or indirectly damages endothelial cells, which induces a number of changes in the microvasculature of the gastric mucosa. In H. pylori-associated conditions, that is, in gastritis, peptic ulcer and gastric carcinoma, there is an increased concentration of angiogenic factors, and subsequently a formation of new blood vessels. However, this early angiogenesis -which is activated to repair the gastric mucosa- is subsequently inhibited in patients with peptic ulcer, and ulcer healing is thus delayed. This may be due to the antiproliferative action of this organism on endothelial cells. While the angiogenic process becomes inhibited in infected patients with peptic ulcer, it remains seemingly active in those with gastritis or gastric cancer. This fact is in support of the notion suggested by various studies that peptic ulcer and gastric cancer are mutually excluding conditions. In the case of gastric cancer, neoangiogenesis would enhance nutrient and oxygen supply to cancer cells, and thus tumor growth and metastatic spread.

Endothelial Cells↗

Gastric MALT lymphoma: clinical characteristics and prevalence of H. pylori infection in a series of 37 cases.

OBJECTIVE: to perform a retrospective review of the clinical characteristics and prevalence of H. pylori infection in patients with gastric MALT lymphoma diagnosed in our hospital during the last 15 years. METHODS: patients with gastric MALT lymphoma diagnosed in our hospital during the last 15 years were retrospectively included. Demographic, clinic, analytic, endoscopic, and histological variables were reviewed. The extension study, the staging classification, and the presence of H. pylori infection were assessed. RESULTS: thirty-seven patients with gastric MALT lymphoma were identified. Mean age was 61 years, with 62% of males. The most common presentation symptom was dyspepsia (76%), followed by digestive bleeding (11%) and constitutional syndrome (8%). At endoscopy, erosive lesions were identified in 41%, and proliferative or exophytic lesions in 43%. Most lymphomas were classified as low-grade (68%). The stage distribution was EI for 56%, EII for 13%, EIII for 3%, and EIV for 28%. The prevalence of H. pylori infection (histology in all cases, rapid urease test in 19%, and 13C-urea breath test in 24%) was 46%. When only low-grade lymphomas in stage EI were considered, H. pylori prevalence increased to 55%. When H. pylori infection was evaluated by 13C-urea breath testing (in addition to histology), the prevalence of H. pylori infection increased to 78%. CONCLUSIONS: it is probable that the reduced H. pylori prevalence found in some studies, as in ours, could be explained by false-negative results obtained when only one diagnostic method was used. Therefore, at least two (invasive) diagnostic methods should be performed. Furthermore, the performance of a non-invasive diagnostic method (such as a 13C-urea breath test) before the exclusion of H. pylori infection should be considered.

Aged↗

Helicobacter pylori: its discovery and relevance for medicine.

In 1979, Warren was first to observe these bacteria in an inflamed gastric epithelium, and subsequently in peptic ulcer-associated gastritis. In 1981, Marshall starts his research and cultivates the bacteria, performs prospective studies, and administers therapy regimens using antibiotics and bismuth salts. The organism was designated Campylobacter-like after its similarity with said genus. In 1984, Marshall manages to meet Koch s postulates using self-inoculation by ingesting a bacterial culture, which resulted in gastritis that was then treated and cured with bismuth salts and metronidazole. The Gastroenterological Society of Australia rejected the abstract with preliminary data. In 1983, "The Lancet" published such data in two brief letters with the same heading, with each being signed by one of these two researchers. Cooperating with microbiologists they classify the new bacteria within the Helicobacter genus as the pylori species. Gastritis and peptic ulcer are currently considered infectious diseases. Their diagnosis and therapy include bacterial detection methods and antibiotics, respectively. In addition, a causal relationship between Helicobacter pylori and both gastric adenocarcinoma and gastric lymphoma has been established, and its association with some extra-digestive conditions has been suggested.

Biomedical Research↗

Is there any correlation between 13C-urea breath test values and response to first-line and rescue Helicobacter pylori eradication therapies?

AIM: To study if there is a correlation between 13C-urea breath test values prior to treatment and the response to first-line and rescue Helicobacter pylori eradication therapies. METHODS: Six-hundred patients with peptic ulcer or functional dyspepsia infected by H. pylori were prospectively studied. Pre-treatment H. pylori infection was established by 13C-urea breath test. Three-hundred and twelve patients were treated with first-line eradication regimen, and 288 received a rescue regimen. H. pylori eradication was defined as a negative 13C-urea breath test, 8 weeks after completion of treatment. RESULTS: H. pylori eradication was achieved in 444 patients. No statistically significant differences were demonstrated when mean delta 13C-urea breath test values were compared between patients with eradication success and failure (49.4+/-33 versus 49.2+/-31). Differences in mean pre-treatment delta 13CO2 between patients with eradication success/failure were not demonstrated either when first-line or rescue regimens were prescribed. With the cut-off point of pre-treatment delta 13CO2 set at 35 units, sensitivity and specificity for the prediction of H. pylori eradication success was 43 and 60%. The area under the receiver operating characteristic curve evaluating all the cut-off points of the pre-treatment delta 13CO2 for the diagnosis of H. pylori eradication was 0.5. Finally, delta 13CO2 values did not influence the eradication in the logistic regression model. CONCLUSION: No correlation was observed between 13C-urea breath test values before treatment and the response to first-line and rescue H. pylori eradication therapies. Therefore, we conclude that the quantification of delta 13CO2 prior to treatment is not useful to predict the success or failure of eradicating therapy.

Antacids↗

Helicobacter pylori first-line treatment and rescue options in patients allergic to penicillin.

BACKGROUND: Helicobacter pylori eradication is a challenge in patients allergic to penicillin, especially those who have failed a first-eradication trial. AIM: To assess the efficacy and tolerability of H. pylori first-line treatment and rescue options in patients allergic to penicillin. METHODS: Prospective single centre study including 40 consecutive treatments administered to patients allergic to penicillin. Therapy regimens: First-line (12 patients) omeprazole, clarithromycin and metronidazole for 7 days; second-line (17 patients) ranitidine bismuth citrate, tetracycline and metronidazole for 7 days; third-line (nine patients) rifabutin, clarithromycin and omeprazole for 10 days; and fourth-line (two patients) levofloxacin, clarithromycin and omeprazole for 10 days. OUTCOME VARIABLE: a negative (13)C-urea breath test 8 weeks after completion of treatment. RESULTS: Per-protocol/intention-to-treat eradication rates were: first-line (64/58%); second-line (ranitidine bismuth citrate; 53/47%); third-line (rifabutin; 17/11%) and fourth-line regimen (levofloxacin; 100/100%). Compliance with treatment was generally good, except with the rifabutin-based regimen, which presented adverse effects in 89% of the patients, including four cases of myelotoxicity. CONCLUSIONS: H. pylori-infected patients who are allergic to penicillin may be treated with a first-line treatment combining a proton-pump inhibitor, clarithromycin and metronidazole. Rescue options may include a regimen with ranitidine bismuth citrate, tetracycline and metronidazole. A levofloxacin-based rescue regimen (with proton-pump inhibitor and clarithromycin) may also represent an alternative, even when two or more consecutive eradication treatments have previously failed. However, rifabutin + clarithromycin + proton-pump inhibitor regimen is ineffective and poorly tolerated.

Anti-Bacterial Agents↗

13C-urea breath test in the management of Helicobacterpylori infection.

The urea breath test is a noninvasive and very accurate test for the diagnosis of Helicobacter pylori infection. However, false negative urea breath test results have been reported to occur in a considerable percentage of the individuals taking proton pump inhibitors; the interval needed to be completely confident that false negative tests had been excluded has varied among the different studies between 6 and 14 days. The impact of H(2)-receptor antagonists on the accuracy of urea breath test remains controversial, although, in contrast with proton pump inhibitors, the data suggest that H(2)-receptor antagonists, for the most part, have little effect on the result of the urea breath test. The urea breath test does not represent a suitable tool for estimating the density of H. pylori colonization. The only quantitative information to be obtained from the urea breath test is that the higher the delta value, the lower the probability of a false-positive urea breath test result. Although some authors have demonstrated a correlation between urea breath test values and histological lesions of the gastric mucosa, the practical utility of this relationship remains unclear. It has been suggested that the pretreatment urea breath test has the potential to identify patients who require modification of the standard therapeutic regimen (for example, prolonging the duration of treatment or increasing the pharmacological dose when bacterial density is high), but other studies could not confirm this relationship. Some studies have shown that the urea breath test is less accurate in patients who have undergone partial gastrectomy. Finally, in contrast with biopsy-based methods, which are responsible for a high number of false-negative results when used to diagnose H. pylori infection in patients with upper gastrointestinal bleeding, urea breath test seems not to be negatively influenced by the presence of this complication.

Breath Tests↗